U.S. patent number 10,980,981 [Application Number 15/968,450] was granted by the patent office on 2021-04-20 for procedural sheath.
This patent grant is currently assigned to ABBOTT CARDIOVASCULAR SYSTEMS, INC. The grantee listed for this patent is Abbott Cardiovascular Systems, Inc.. Invention is credited to Aaron M. Fortson.
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United States Patent |
10,980,981 |
Fortson |
April 20, 2021 |
Procedural sheath
Abstract
A procedural sheath and methods of use that assists in
maintaining a fluid path while the procedural sheath is positioned
within a vascular conduit of a patient. The procedural sheath
includes one or more channels extending longitudinally along a
working length of the body of the sheath. Each channel includes one
or more fluid paths configured to allow blood to flow from the
vascular conduit into a device receiving lumen of the sheath. One
or more elongate members selectively coupled to the body
operatively cooperate with the channels to fluidly control fluid
access into the device receiving lumen through the fluid paths.
Inventors: |
Fortson; Aaron M. (Fremont,
CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Abbott Cardiovascular Systems, Inc. |
Santa Clara |
CA |
US |
|
|
Assignee: |
ABBOTT CARDIOVASCULAR SYSTEMS,
INC (Santa Clara, CA)
|
Family
ID: |
1000005498056 |
Appl.
No.: |
15/968,450 |
Filed: |
May 1, 2018 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20190336731 A1 |
Nov 7, 2019 |
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
25/0662 (20130101); A61M 25/0097 (20130101); A61M
2210/005 (20130101); A61M 2210/12 (20130101) |
Current International
Class: |
A61M
25/06 (20060101); A61M 25/00 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Woo; Julian W
Attorney, Agent or Firm: Workman Nydegger Shen; Randy
Claims
What is claimed is:
1. A procedural sheath comprising: an elongate body having a
proximal end, a distal end, a device receiving lumen extending from
the proximal end to the distal end, and a channel extending along a
working length of the body, the channel comprising a first end
region and a second end region, the device receiving lumen being
generally uniform in diameter along the working length of the body;
an elongate member selectively disposed within the channel of the
body; and a plurality of fluid paths formed in a base of the
channel, each of the plurality of fluid paths includes an inlet in
the base of the channel and an outlet at the device receiving
lumen, wherein the elongate member operatively cooperates with the
channel and fluidly controls fluid access into the device receiving
lumen of the body through the plurality of fluid paths by
selectively opening and closing the inlets, wherein an intermediate
portion of the elongate member, between the first end region and
the second end region, is configured to protrude outwardly from
within the channel during selective opening and closing of the
inlets, and wherein a first portion of the elongate member extended
towards the first end region and a second portion of the elongate
member extended towards the second end region remains within the
channel.
2. The procedural sheath of claim 1, wherein the channel extends
longitudinally along at least about 70% of the working length of
the body.
3. The procedural sheath of claim 1, wherein the device receiving
lumen has a diameter of at least about 0.31 inches.
4. The procedural sheath of claim 1, wherein an outer diameter of
the body is between about 0.36 inches and 0.47 inches.
5. The procedural sheath of claim 1, wherein the elongate member
selectively moves between about 0.5 mm and 1.5 mm radially
outwardly from the body.
6. The procedural sheath of claim 5, further comprising a hub
operatively coupled to the proximal end of the body, wherein a
manipulation of the hub selectively moves the elongate member
radially outwardly from the body.
7. The procedural sheath of claim 1, further comprising a plurality
of supporting regions arranged along the channel region.
8. The procedural sheath of claim 7, wherein each supporting region
overlaps at least a portion of the elongate member and limits
radial movement of the elongate member.
9. The procedural sheath of claim 8, wherein a portion of the
elongate member between two adjacent supporting regions selectively
moves between about 0.5 mm and 1.5 mm radially outwardly from the
body.
10. The procedural sheath of claim 1, wherein the body comprises a
plurality of channel regions and a plurality of elongate members,
the plurality of channel regions extending along a working length
of the body.
11. A large-bore procedural sheath comprising: a body comprising a
proximal end, a distal end, and a length extending therebetween; a
plurality of channels on an exterior surface of the body extending
longitudinally along at least about 70% of the length of the body,
each of the plurality of channels comprising a first end region and
a second end region; a device receiving lumen having a
substantially uniform diameter along a length of the device
receiving lumen from the proximal end to the distal end of the
body, the lumen configured to receive a procedural device therein;
a plurality of fluid paths formed in each channel of the plurality
of channels, each of the plurality of fluid paths comprising an
inlet formed at one of the plurality of channels and an outlet
formed at the device receiving lumen, wherein the device receiving
lumen fluidly communicates with the plurality of channels through
the plurality of fluid paths; and a plurality of elongate members
that are selectively disposed within the plurality of channels,
each elongate member operatively cooperating with a channel of the
plurality of channels to fluidly control fluid access into the
device receiving lumen of the body through the plurality of fluid
paths by selectively opening and closing the inlets, wherein an
intermediate portion of the elongate member, between the first end
region and the second end region, is configured to protrude
outwardly from within the channel during selective opening and
closing of the inlets, and wherein a first portion of the elongate
member extended towards the first end region and a second portion
of the elongate member extended towards the second end region
remains within the channel.
12. The large-bore procedural sheath of claim 11, the body further
comprising a wall having a thickness between about 0.05 inches and
0.1 inches extending from the exterior surface of the body to the
device receiving lumen.
13. The large-bore procedural sheath of claim 12, wherein each of
the plurality of channel regions comprises a recessed portion
extending into the wall from the exterior surface of the body, a
depth of the recessed portion being between about 0.04 inches and
0.9 inches.
14. The large-bore procedural sheath of claim 13, wherein the wall
maintains a radial force transferred to the body of between 1
Newton and 7 Newtons.
15. The large-bore procedural sheath of claim 11, wherein an outer
diameter of the body is between about 0.36 inches and 0.47
inches.
16. The large-bore procedural sheath of claim 11, wherein the
device receiving lumen has a diameter of between about 0.31 inches
and 0.37 inches.
17. The large-bore procedural sheath of claim 11, wherein each
fluid path comprises a perforation.
18. A procedural sheath comprising: a body having a length
extending between a proximal end and a distal end thereof; a device
receiving lumen extending longitudinally inside the body, the
device receiving lumen having a substantially uniform diameter
along a length of the lumen from the proximal end to the distal end
of the body; a channel extending on the surface of the body
longitudinally along at least about 70% of the length of the body;
a plurality of support regions disposed along a length of the
channel; a plurality of fluid paths formed between the channel and
the device receiving lumen; an elongate member; and a hub coupled
to the proximal end of the body, the hub being configured to
selectively move the elongate member between a first configuration
and a second configuration, wherein, in the first configuration,
the elongate member is received within the channel and the elongate
member covers the plurality of fluid paths in the channel so that
the device receiving lumen does not fluidly communicate with the
channel through the plurality of fluid paths, and wherein, in the
second configuration, portions of the elongate member that are
disposed between support regions along the length of the channel
extend radially outward from the channel, the elongate member being
in the second configuration and uncovering the plurality of fluid
paths in the channel so that the device receiving lumen fluidly
communicates with the channel through the plurality of fluid paths
and the elongate member exerts a force against an interior surface
of a vascular wall.
19. The procedural sheath of claim 18, wherein each of the
plurality of fluid paths includes an inlet at the channel and an
outlet at the device receiving lumen.
20. The procedural sheath of claim 18, wherein each elongate member
comprises a shape memory material.
21. The procedural sheath of claim 18, wherein each support region
overlaps at least a portion of the elongate member and limits
radial movement of the elongate member.
22. The procedural sheath of claim 18, wherein the channel extends
helically around the body.
23. A method for performing an intravascular procedure while
maintaining a fluid path through a vascular conduit, comprising:
providing a procedural sheath, the procedural sheath comprising: a
body comprising a channel with a plurality of fluid paths formed in
a base of the channel, each of the plurality of fluid paths
including an inlet in the base of the channel and an outlet at a
device receiving lumen of the body, the device receiving lumen
being generally uniform in diameter along the length of the body;
an elongate member selectively coupled to the body, the elongate
member operatively cooperating with the channel and fluidly
controlling fluid access into the device receiving lumen of the
body through the plurality of fluid paths by selectively closing
the inlets; advancing the procedural sheath into the vascular
conduit; moving the elongate member radially outwardly from the
body to push radially outwardly on an inside surface of the conduit
and allow fluid access into the device receiving lumen of the body;
and advancing a procedural device into the device receiving lumen
of the body.
24. The method of claim 23, further comprising: withdrawing the
procedural device; moving the elongate member radially inwardly
toward the body; and withdrawing the procedural sheath from the
vascular conduit of the patient.
25. The method of claim 23, further comprising: before advancing
the procedural sheath into the vascular conduit, creating an
insertion site for access to a femoral artery; wherein advancing
the procedural sheath into the vascular conduit comprises advancing
the procedural sheath toward a heart.
26. The method of claim 23, further comprising: before advancing
the procedural sheath into the vascular conduit, creating an
insertion site for access to vasculature that is anterior to a
knee; wherein advancing the procedural sheath into the vascular
conduit comprises advancing the procedural sheath toward an ankle
or foot.
27. The method of claim 23, wherein the procedural device comprises
a guidewire.
28. The method of claim 23, wherein the procedural device comprises
a catheter configured to perform an embolism occlusion
procedure.
29. The method of claim 23, wherein the procedural device comprises
a balloon catheter.
30. The method of claim 23, wherein moving the elongate member
radially outwardly from the body comprises manipulating a hub
disposed at a proximal end of the body.
Description
BACKGROUND OF THE INVENTION
1. The Field of the Invention
The present invention relates generally to a procedural sheath and
methods of use. More particularly, the present invention relates to
a procedural sheath that helps maintain a fluid path while the
procedural sheath is positioned within a vascular conduit or lumen
to aid with performance of diagnostic or therapeutic
procedures.
2. The Relevant Technology
A variety of sheaths and catheters are known in the art for
treating the luminal system of a patient. Of such sheaths and
catheters, many are directed to treating the cardiovascular system
of a patient.
For example, as part of a diagnostic or therapeutic procedure,
guidewires are inserted into a patient's vasculature through
another catheter or sheath, such as an introducer. Following
guidewire placement, medical professionals, such as physicians,
clinicians, etc., advance other procedural devices such as
catheters. occlusion devices, scaffolds, additional sheaths. or
other diagnostic or therapeutic devices to a treatment region, in
order to accommodate such devices, a catheter or sheath must have a
sufficiently large bore through which the device can be passed.
However, during certain intravascular procedures, maintaining a
large-bore sheath within the vasculature can lead to complications
due to large-bore sheaths necessarily having larger outer diameters
than. for example, small-bore sheaths that cannot accommodate the
devices mentioned above. The large diameters of large-bore sheaths
may present a greater risk of blocking blood flow through the
vasculature in which the sheath is placed. For example, inserting a
large-bore sheath into the femoral artery of a patient and towards
the heart may block blood flow to the lower limbs. This blockage
can lead to ischemia in the lower limb tissue of a patient due to a
lack of oxygen being delivered to the tissue. Ischemia can cause
pain or, in more critical cases, tissue loss.
The likelihood of these complications arising increases as the size
of the vasculature decreases and as the duration of the procedure
increases. For example, a patient may be at more risk of ischemia
when a large-bore sheath is inserted at a site anterior to the knee
and extended through the vasculature of the patient towards the
ankle or foot, where the size of the vasculature decreases.
Also, procedures that require a large-bore sheath to be inserted in
the vasculature for an extended period of time increases the risk
of tissue loss due to ischemia, as the tissue may be lacking
sufficient oxygen for a long period of time. Extended procedures
such as these may include the use of embolic devices to occlude
aneurysms, implanting scaffolds, stent delivery, or the like.
Accordingly, there exists a need for large-bore sheath systems,
methods, and apparatus that can accommodate a number of procedural
devices within the sheath without significantly blocking blood flow
through the vasculature of a patient.
BRIEF SUMMARY OF THE INVENTION
The present invention relates generally to a procedural sheath and
methods of use. More particularly, the present invention relates to
a procedural sheath that helps maintain a fluid path while the
procedural sheath is positioned within a vascular conduit or lumen
to aid with performance of diagnostic or therapeutic procedures.
For example, in one embodiment, a procedural sheath includes a body
comprising one or more channels and one or more fluid paths formed
in a base of each channel. Each of the fluid paths may include an
inlet in the base of the channel and an outlet at a device
receiving lumen of the body. The device receiving lumen is
generally uniform in diameter along the length of the body.
In one embodiment, a procedural sheath includes an elongate member
selectively coupled to the body. The elongate member cooperates
with the channel and fluidly controls fluid access into the device
receiving lumen by selectively closing the inlets of the fluid
paths within the channel.
In one embodiment, according to the present disclosure, a
large-bore procedural sheath includes a body that has a proximal
end, a distal end, and a length extending therebetween. Also, a
plurality of channels extend on the surface of the body and
longitudinally for at least about 70% of the length. In one
embodiment, the large-bore sheath includes a device receiving lumen
that has a substantially uniform diameter along the length of the
lumen from the proximal end to the distal end of the body. The
lumen is configured to receive a procedural device therein. Also,
in one embodiment according to the present disclosure, the
large-bore procedural sheath includes a plurality of fluid paths
formed in each channel. In one embodiment, each fluid path includes
an inlet at the channel and an outlet at the device receiving lumen
so that the device receiving lumen is in fluid communication with
the channel through the fluid paths.
In one embodiment according to the present disclosure, the
procedural sheath includes an elongate body and a hub coupled to
the proximal end of the body. The hub is configured to selectively
move an elongate member between a first configuration and a second
configuration. In one embodiment, the first configuration includes
a plurality of elongate members received into a plurality of
channels and the second configuration includes the plurality of
elongate members extending radially outwardly from the elongate
body of the procedural sheath. In one embodiment, in the second
configuration, a plurality of fluid paths formed in the channels
are uncovered to allow fluid communication between a lumen of the
sheath and the channels. Also, in the second configuration, the
outwardly extending elongate members exert a force against an
interior surface of the wall of a vasculature in which the sheath
is disposed.
In one embodiment according to the present disclosure, a method for
performing an intravascular procedure while maintaining a fluid
path through a vascular conduit of a patient includes a first step
of providing a procedural sheath according to the present
disclosure. In one embodiment of the method, a further step
includes advancing the procedural sheath into a vascular conduit of
a patient. One embodiment of the method also includes moving the
elongate member radially outwardly from the body to push radially
outwardly on an inside surface of the conduit and allow fluid
access into the device receiving lumen of the body. One embodiment
of the method also includes advancing a procedural device into the
device receiving lumen of the body.
These and other objects and features of the present invention will
become more fully apparent from the following description and
appended claims or may be learned by the practice of the invention
as set forth hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
To further clarify the above and other advantages and features of
the present invention, a more particular description of the
invention will be rendered by reference to specific embodiments
thereof which are illustrated in the appended drawings. It is
appreciated that these drawings depict only illustrated embodiments
of the invention and are therefore not to be considered limiting of
its scope. The invention will be described and explained with
additional specificity and detail through the use of the
accompanying drawings in which:
FIG. 1 illustrates a procedural sheath according to an embodiment
of the present disclosure;
FIG. 2A illustrates a perspective view of the distal end of a
procedural sheath according to an embodiment of the present
disclosure;
FIG. 2B illustrates a transverse cross-sectional view thereof;
FIG. 2C illustrates a longitudinal cross-sectional view
thereof;
FIG. 3A illustrates a transverse cross-sectional view of a
procedural sheath inserted into the vasculature of a patient
according to an embodiment of the present disclosure;
FIG. 3B illustrates a longitudinal cross-sectional view
thereof;
FIG. 4A illustrates a perspective view of the distal end of a
procedural sheath according to an embodiment of the present
disclosure;
FIG. 4B illustrates a transverse cross-sectional view thereof;
FIG. 4C illustrates a longitudinal cross-sectional view
thereof;
FIG. 5A illustrates a longitudinal cross-sectional view of a
procedural sheath inserted into the vasculature of a patient
according to an embodiment of the present disclosure;
FIG. 5B illustrates a transverse cross-sectional view thereof;
FIG. 6A illustrates a perspective view of the distal end of a
procedural sheath according to an embodiment of the present
disclosure;
FIG. 6B illustrates a close-up perspective view thereof;
FIG. 6C illustrates a transverse cross-sectional view of the
procedural sheath illustrated in FIGS. 6A and 6B;
FIG. 7A illustrates a transverse cross-sectional view of a
procedural sheath inserted into the vasculature of a patient
according to an embodiment of the present disclosure;
FIG. 7B illustrates a transverse cross-sectional view thereof;
FIG. 8 illustrates a perspective view of the distal end of a
procedural sheath according an embodiment of the present
disclosure;
FIG. 9 illustrates a perspective view of the distal end of a
procedural sheath according an embodiment of the present
disclosure;
FIG. 10 illustrates a longitudinal cross-sectional view of a
procedural sheath according to an embodiment of the present
disclosure;
FIG. 11 illustrates a longitudinal cross-section view of a
procedural sheath according to an embodiment of the present
disclosure;
FIG. 12 illustrates a longitudinal cross-section view of an
elongate member according to an embodiment of the present
disclosure;
FIG. 13 illustrates a longitudinal cross-section view of an
elongate member expanded outwardly from the body of a sheath
according to an embodiment of the present disclosure; and
FIG. 14 illustrates a schematic representation of a method for
performing a procedure using a procedural device according to the
present disclosure.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
One or more specific embodiments of the present disclosure will be
described below. In an effort to provide a concise description of
these embodiments, some features of an actual embodiment may be
described in the specification. It should be appreciated that in
the development of any such actual embodiment, as in any
engineering or design project, numerous embodiment-specific
decisions will be made to achieve the developers' specific goals,
such as compliance with system-related and business-related
constraints, which may vary from one embodiment to another. It
should further be appreciated that such a development effort might
be complex and time consuming, but would nevertheless be a routine
undertaking of design, fabrication, and manufacture for those of
ordinary skill having the benefit of this disclosure.
One or more of the embodiments of the present disclosure may
generally relate to a procedural sheath and methods of use. More
particularly, the present invention relates to a procedural sheath
that helps maintain a fluid path while the procedural sheath is
positioned within a vascular conduit or lumen to aid with
performance of diagnostic or therapeutic procedures. For example,
in one embodiment, a procedural sheath includes a body comprising
one or more channels and one or more fluid paths formed in a base
of each channel. Each of the fluid paths may include an inlet in
the base of the channel and an outlet at a device receiving lumen
of the body. The device receiving lumen is generally uniform in
diameter along the length of the body.
In one embodiment, a procedural sheath includes an elongate member
selectively coupled to the body. The elongate member cooperates
with the channel and fluidly controls fluid access into the device
receiving lumen by selectively closing the inlets of the fluid
paths within the channel.
In one embodiment, according to the present disclosure, a
large-bore procedural sheath includes a body that has a proximal
end, a distal end, and a length extending therebetween. Also, a
plurality of channels extend on the surface of the body and
longitudinally for at least about 70% of the length. In one
embodiment, the large-bore sheath includes a device receiving lumen
that has a substantially uniform diameter along the length of the
lumen from the proximal end to the distal end of the body. The
lumen is configured to receive a procedural device therein. Also,
in one embodiment according to the present disclosure, the
large-bore procedural sheath includes a plurality of fluid paths
formed in each channel. In one embodiment, each fluid path includes
an inlet at the channel and an outlet at the device receiving lumen
so that the device receiving lumen is in fluid communication with
the channel through the fluid paths.
In one embodiment according to the present disclosure, the
procedural sheath includes an elongate body and a hub coupled to
the proximal end of the body. The hub is configured to selectively
move an elongate member between a first configuration and a second
configuration. In one embodiment, the first configuration includes
a plurality of elongate members received into a plurality of
channels and the second configuration includes the plurality of
elongate members extending radially outwardly from the elongate
body of the procedural sheath. In one embodiment, in the second
configuration, a plurality of fluid paths formed in the channels
are uncovered to allow fluid communication between a lumen of the
sheath and the channels. Also, in the second configuration, the
outwardly extending elongate members exert a force against an
interior surface of the wall of a vasculature in which the sheath
is disposed.
In one embodiment according to the present disclosure, a method for
performing an intravascular procedure while maintaining a fluid
path through a vascular conduit of a patient includes a first step
of providing a procedural sheath according to the present
disclosure. In one embodiment of the method, a further step
includes advancing the procedural sheath into a vascular conduit of
a patient. One embodiment of the method also includes moving the
elongate member radially outwardly from the body to push radially
outwardly on an inside surface of the conduit and allow fluid
access into the device receiving lumen of the body. One embodiment
of the method also includes advancing a procedural device into the
device receiving lumen of the body.
The procedural sheath of the present disclosure may enable medical
professionals, such as physicians, clinicians, etc., to reduce the
risk of ischemia and other complications while performing
intravascular procedures. The procedural sheath of the present
disclosure may provide a device receiving lumen large enough to
accommodate a variety of procedural devices without significantly
blocking blood flow through the vasculature in which the sheath is
placed. As a result, the sheath may reduce pain and tissue damage
in patients undergoing procedures that require access through
small-diameter vasculature and/or procedures that require
intravascular access for extended periods of time.
Turning now to the figures, FIG. 1 illustrates a procedural sheath
100 according to an embodiment of the present disclosure. The
illustrated sheath 100 includes an elongate body 102 extending from
a proximal end 104 to a distal end 106. In one embodiment, the
sheath 100 may have a length extending between the proximal end 104
and the distal end 106 of between about 25 cm and 120 cm. In
another embodiment, the length may be between about 40 cm and 110
cm. In yet another embodiment, the length may be between about 55
cm and 100 cm. Additionally, one or more embodiments of the sheath
100 may have a length between the distal and 106 and the proximal
end 104 of about 65 cm, 70 cm, 85 cm, or 90 cm. The sheath 100 may
also include a stress relief feature 108 and a hub 110 disposed at
the proximal end 104 thereof. In addition, the sheath 100 may
include a tip 112 disposed at the distal end 106. One or more
channels 114 may extend longitudinally along a substantial portion
of the working length of the body 102.
In addition to the features of the sheath 100 mentioned above, the
sheath 100 may also include an interior device receiving lumen
configured to receive a procedural device. The device receiving
lumen (not illustrated in FIG. 1) may extend from the proximal end
104 to the distal end 106 of the sheath 100. The device receiving
lumen may be configured so that a procedural device, such as, for
example, an embolic coil or guidewire, may be inserted proximally
through the hub 110 and into the sheath 100. The procedural device
may be advanced through the device receiving lumen to the distal
end 106 of the sheath 100 and out an opening 116 in the tip 116, as
may be required for certain procedures.
The body 102 of the sheath may be made of various bio-compatible
materials that maintain proper flexibility for navigating the
vasculature of a patient as well as proper elasticity and/or
stiffness to prevent kinking. Such materials, which may be well
known in the art, may include, but are not limited to,
Polyethylene, Fluorinated Ethylene Propylene, or other
Fluoropolymers. In addition, these materials may be coated with
lubricious coatings, either hydrophilic or hydrophobic. Strong and
lubricious materials are preferred. The body 102 may be extruded or
otherwise formed using methods that are generally known in the
art.
The stress relief feature 108 of the sheath 100 may also be made of
similar materials. The stress relief feature 108 may be more or
less stiff than the body 102 and shaped so as to relieve/distribute
stress concentrations that may occur at the proximal end 104 of the
body 102, where the body 102 and hub 110 meet. The stress relief
feature 108 may be molded or otherwise formed with the body 102 and
include an inner lumen (not shown) for passing a procedural device
through the hub 110 and into the device receiving lumen of the body
102.
As noted above, the sheath 100 may include a tip 112 disposed at
the distal end 106 of the body 102. The tip 112 may be made of a
more rigid material than that of the body 102 and include an
opening 116 through which a procedural device may pass. The tip 112
preferably may comprise a radiopaque material that can be imaged
from outside the body to assist a physician or other medical
professional in locating and properly positioning the sheath 100
within the vasculature of a patient as required by a procedure. For
example, the tip 112 may comprise materials such as steel,
stainless steel, cobalt-chromium, titanium, Nitinol, or any number
of polymers loaded with metal such as barium sulfate, Bismuth,
Tungsten, and the like.
The tip 112 may also provide a portion of the body 102 that more
reliably maintains its shape and opening 116 to ensure access to
the vasculature from the device receiving lumen inside the body 102
of the sheath. The tip 112 may be extruded or molded together with
the body 102, molded separately and then molded or adhered to the
body 102, or otherwise permanently disposed at the distal end 106
thereof.
FIG. 1 also illustrates one or more channels 114 extending
longitudinally along the outer surface of the body 102. In the
illustrated embodiment, the channels may run substantially parallel
to one another and be spaced around the circumference of the body
102. The number and configuration of the channels 114 may vary in
different embodiments. For example, in one embodiment, the body 102
of the sheath 100 may include 4 channels 114 spaced around the body
102 and extending longitudinally from the proximal end 104 to the
distal end 106. In one embodiment, the body 102 may include 3
channels 114, or less than 3 channels. In yet another embodiment,
the body 102 may include between 4 and 8 channels 114. In yet
another embodiment, the body 102 may include more than 8 channels
114 extending longitudinally thereon.
In the various embodiments of the sheath 100 described herein, the
channels 114 may extend longitudinally along a substantial portion
of working length of the body 102. For example, the channels 114
may extend along at least about 70% of the working length of the
body 102. In one embodiment, the channels 114 may extend along at
least about 80% of the working length of the body 102. In yet
another implementation, the channels 114 may extend between 85% and
95% along the working length of the body 102. For example, in one
embodiment, the channels 114 may extend 90% along the working
length of the body 102 of the sheath 100. The channels 114 may
terminate at the tip 112 disposed at the distal end 106 and about
10 cm distal to the strain relief feature 108 at the proximal end
104.
FIG. 2A shows a close-up view of the distal end 106 of an
embodiment of a sheath 200 having a plurality of channels 114
extending longitudinally along the working length of the body 102.
In the illustrated embodiment, each of the channels 114 may include
one or more fluid paths 202 formed in each channel 114. FIG. 2B
illustrates a transverse cross-sectional view of the body 102
illustrated in FIG. 2A. As shown in FIG. 2B, each fluid path 202
may include an inlet 204 formed at the channel 114 and an outlet
206 formed at a device receiving lumen 208 extending through an
interior of the body 102. In one implementation, each fluid path
202 may be formed as a perforation extending between an inlet 204
and outlet 206. Fluid, such blood flowing through the vasculature
of a patient, may pass through the fluid path 202 from outside the
body 102 of the sheath into the device receiving lumen 208.
FIG. 2B also illustrates cross-sectional views of the channels 114
spaced around the body 102 of the sheath 100. In the illustrated
embodiment, the body 102 includes 6 channels 114 spaced evenly
around the circumference thereof. However, as discussed above, the
number and spacing of the channels may vary in different
embodiments. As shown in the illustrated embodiment, the channels
114 consist of semi-circular cutouts of material forming portions
of the body 102 that are recessed from the outer surface of the
body 102. In one or more other embodiment, the channels 114 may
have cross-sectional shapes other than semi-circular. For example,
in one or more embodiments, the cross-sectional shape of each
channel may be rectangular, triangular, or otherwise polygonal in
shape.
The cross-sectional view of the body 102 illustrated in FIG. 2B
also shows a body wall 210 defined by material between an outer
surface of the body 102 and the device receiving lumen 208. Because
the channels 114 may comprise material removed from the wall 210,
the thickness of the wall 210 may vary around the circumference of
the body 102. For example, a portion of the wall 210 that does not
include a channel 114 may be thicker than a portion of the wall 210
that does include a channel 114. Thus, the thinnest portion of the
wall 210 may be where the lowest point, or base, of a channel 114
is disposed. In one embodiment, a thickness T1 of the wall 210, at
a point where no channel resides, may be between about 0.05 inches
and 0.1 inches. In another embodiment, the thickness T1 of the wall
210 may be between about 0.04 and 1.2 inches. In yet one or more
other embodiments, the thickness T1 of the wall 210 may be between
about 0.02 inches and 0.03 inches.
As shown in the illustrated embodiment of FIG. 2B, each fluid path
202 may be disposed through the thinnest portion of the wall 210.
In other words, each inlet 204 of each fluid path 202 may be
disposed at the base of each of the channels 114. In one
embodiment, each channel may have a depth of between about 0.04
inches and 0.9 inches. In another embodiment, each channel may have
a depth ranging between about 0.03 inches and 1.1 inches. In any
case, the depth of each channel 114 is preferably less than the
thickness of the wall 210 so that channels 114 do not extend all
the way through the wall 210. Also, each channel may have a width
W1 at the surface of the body 102 of less than about 0.1
inches.
FIG. 2B also illustrates an outer diameter of the body D1 and a
diameter D2 of the device receiving lumen 208. In one embodiment,
the outer diameter D1 may be between about 0.36 inches and 0.47
inches. In another embodiment, outer diameter D1 may be between
about 0.35 inches and 0.49 inches. In any case, the outer diameter
of the body 102 is equal to the diameter of the device receiving
lumen 208 plus the wall thickness T1. In one embodiment, the
diameter D2 of the device receiving lumen 208 may be between about
0.31 inches and 0.37 inches. In one embodiment, the diameter D2 may
be between about 0.33 inches and 0.35 inches. For example, in one
embodiment, the diameter D2 may be 0.34 inches. Also, for example,
in another embodiment, the diameter D2 may be 0.32 inches or 0.36
inches. Preferably, the diameter D2 of the device receiving lumen
208 may be such that a 24-French procedural device can be inserted
and advanced therethrough.
FIG. 2C illustrates another cross-sectional view of the sheath 200
illustrated in FIG. 2A. The cross-section view of FIG. 2C is taken
through the plane denoted as A-A in FIG. 2C. As seen in FIGS. 2B
and 2C, the device receiving lumen has a circular cross-sectional
area that extends longitudinally along the length of the body 102.
The diameter D2 of the device receiving lumen 208 may be
substantially uniform along the length of the body 102 to the tip
112, as well as radially uniform around the cross-sectional
diameter D2, shown in FIG. 2B. The uniformity of the device
receiving lumen 208 may provide a smooth, unobstructed path through
which a procedural device may be advanced.
FIG. 2C also illustrates a cross-sectional view of the wall 210 of
the body 102 taken through plane A-A, as denoted in FIG. 2B. The
upper wall 210a of FIG. 2C is thinner than the bottom wall 210b due
to the plane A-A crossing through a channel 114 at the top and not
at the bottom. Thus, fluid channels 202 are visible in the top wall
portion 210a and not in the bottom wall portion 210b.
Likewise, FIG. 3B is a cross-sectional view of an embodiment of a
sheath 300 taken through plane A-A, as denoted in FIG. 3A. FIG. 3A
is a cross-sectional view of a sheath 300 similar to the sheath 200
illustrated in FIG. 2B, but where the sheath 300 is disposed within
a conduit of the vasculature of a patient. Referring first to FIG.
3A, the sheath 300 may be disposed so that the wall 210 of the body
102 presses against the vascular wall 30. FIG. 3A further
illustrates a space 302 created between the wall 210 of the body
102 and the vasculature wall 30. The inlet 204 of each fluid path
202 may therefore be disposed at the space 302 provided by the
channels 114. Thus, fluid, such as blood within the conduit 10 of a
patient's vasculature 20 residing in the spaces 302, may enter into
the device receiving lumen 208 through the various fluid paths 202.
Once the blood enters the device receiving lumen 208, the blood may
continue to be pumped through the vascular conduit 10, carrying
oxygen to the tissue of the patient as needed.
It is noted, for clarification with reference to FIG. 3B, that the
spaces 302 are visible between the upper sheath wall 210a and
vascular wall 30a but not between lower sheath wall 210b and
vascular wall 30b. This is because the viewing plane of FIG. 3B is
taken through the cross-sectional plane A-A, as denoted in FIG. 3A.
This plane A-A passes through a channel 114 at the top wall 210a
and not through a channel 114 at the bottom wall 210b. Thus, the
wall 210 may press against the vascular wall 30 around the
circumference of the body 102, except at the spaces 302 provided by
the channels 114. As such, the view illustrated in FIG. 3B shows
the bottom wall 210b close to, or in contact with, the vascular
wall 30b and a space 302 provided between the upper sheath wall
210a and vascular wall 30a.
It is also noted that the material and wall thickness T1 of the
body 102 may be configured such that forces exerted radially
inwardly onto the sheath 300 by the vasculature 20 are insufficient
to collapse the body 102. For example, in one embodiment, the wall
210 maintains a radial force transferred from the elongate members
402 to the body 102 of between about 1 Newton and 7 Newtons. In
another embodiment, the wall 210 maintains a radial force of
between about 0.5 to 10 Newtons. As such, the sheath 300 may
maintain an open device receiving lumen 208 through which blood or
other fluid may pass when the sheath 300 is advanced through the
vasculature of a patient.
FIGS. 3A and 3B further illustrate a procedural device 40 that has
been advanced through the device receiving lumen 208 of the sheath
300. As discussed above, the sheath 300 may be a large bore sheath
configured to accommodate a procedural device of at least about
24-French. The procedural device 40 may be advanced from the
proximal end 104 of the sheath 300, through the device receiving
lumen 208 to the distal end 106, and additionally through the
opening 116 in the tip 112. Thus, a physician or other medical
professional may be able to perform various therapeutic,
corrective, implantation, or other intravascular procedures through
the sheath 300 without significantly blocking blood flow through
the vasculature 20 in which the sheath 300 is advanced.
Turning now to FIGS. 4A through 4C, another embodiment of a sheath
400 is illustrated. In particular, FIG. 4A illustrates a
perspective view of the distal end 106 of the sheath 400, while
FIGS. 4B and 4C illustrate various cross-sectional views thereof.
As shown by FIG. 4A, the sheath 400 may include a body 102, tip
112, and one or more channels 114. Additionally, the sheath 400 may
include one or more elongate members 402 selectively coupled to the
body 102 and extending longitudinally along the body 102,
cooperating with the channels 114.
For example, as shown in the transverse cross-section view of FIG.
4B, the elongate members 402 may be disposed within the channels
114 so that the elongate members 402 do not extend beyond the outer
diameter D2 of the body 102. Furthermore, in one embodiment, the
elongate members 402 may be shaped such that the elongate members
402 coincide in shape with the channels 114 and block off the
inlets 204 of the fluid paths 202. The illustrated embodiment of
FIGS. 4A through 4C includes 4 channels 114 spaced about the
circumference of the body 102 with 4 elongate members 402 disposed
therein. As noted above, other embodiments may include more or less
than 4 channels 114. Also, as discussed above, the dimensions,
configurations, and shape of the wall 210, channels 114, fluid
paths 202, and device receiving lumen 208 may be similar to other
embodiments described herein.
For example, in one embodiment, the outer diameter D3 may be
between about 0.36 inches and 0.47 inches. In another embodiment,
outer diameter D3 may be between about 0.35 inches and 0.49 inches.
In any case, the outer diameter of the body 102 is equal to the
diameter of the device receiving lumen 208 plus the wall thickness
T2. In one embodiment, the diameter D4 of the device receiving
lumen 208 may be between about 0.31 inches and 0.37 inches. In one
embodiment, the diameter D4 may be between about 0.33 inches and
0.35 inches. For example, in one embodiment, the diameter D4 may be
0.34 inches. Also, for example, in another embodiment, the diameter
D4 may be 0.32 inches or 0.36 inches. Preferably, the diameter D4
of the device receiving lumen 208 may be such that a 24-French
procedural device can be inserted and advanced therethrough.
The elongate members 402 illustrated in FIGS. 4A through 4C may
extend longitudinally along the working length of the body 102 of
the sheath 400 along with the channels 114 as described herein.
Thus, the elongate members 402 may extend along at least about 70%
of the working length of the body 102. In one embodiment, the
elongate members 402 may extend along at least about 80% of the
working length of the body 102. In yet another implementation, the
elongate members 402 may extend between 85% and 95% along the
working length of the body 102. For example, in one embodiment, the
elongate members 402 may extend 90% along the working length of the
body 102 of the sheath 100. The elongate members 402 may terminate
at the tip 112 disposed at the distal end 106 and about 10 cm
distal to the strain relief feature 108 at the proximal end
104.
In addition to the elongate members 402 illustrated in FIGS. 4A
through 4C, FIGS. 4A and 4C also illustrate one or more support
regions 404 dispersed along the length of the elongate members 402.
In one embodiment, the support regions 404 may overlap the elongate
members 402 and restrict the outward radial movement of the
elongate members 402 away from the body 102. For example, as seen
in the cross-sectional view of FIG. 4C, one or more support regions
404 are disposed radially outward form the elongate members 404.
Thus, in one or more embodiments, the elongate members 402 may be
disposed within the channels 114 and below the support regions
404.
The support regions 404 may be formed integrally with the material
of the body 102 or separately formed and molded, or otherwise
adhered, to the body 102 so that the support regions 404 span the
channels 114 over the elongate members 404. The number and distance
between adjacent support regions 404 may vary. Also, the thickness
and strength of the support members 404 are preferably sufficient
to restrain at least portions of the elongate members 402 within
the channels 114. The thickness, length, and width of the support
regions 404 may vary in different embodiments.
FIGS. 5A and 5B illustrate cross-sectional views of an embodiment
of a sheath 500 similar to the embodiment illustrated in FIG. 4A.
However, in the illustrated embodiment, the sheath 500 has been
advance into the vasculature 20 of a patient and a procedural
device 40 has been advanced through the device receiving lumen 208.
The outer diameter D3 of the sheath 500 is such that the wall 210
of the body 102 presses against or contacts the vascular wall 30 of
the patient, similar to other embodiments described herein in
reference to FIGS. 3A and 3B. However, in the embodiment of the
sheath 500 illustrated in FIGS. 5A and 5B, little or no space is
present between the wall 210 of the body 102 and the vascular wall
30 because the elongate members 402 are received within the
channels 114 instead.
Thus, in the configuration of the embodiments shown in FIGS. 4A
through 5B, little or no blood flowing through the vasculature 20
of the patient may enter the device receiving lumen 208. However,
the elongate members 402 may be selectively moved to extend
radially outwardly from the body 102, as shown in FIGS. 6A through
7B. Along these lines, FIG. 6A illustrates a perspective view of
the distal end 106 of a sheath 600, similar to the sheath 500
illustrated in FIGS. 4A through 5B, but where the elongate members
402 have been selectively moved radially outwardly from the body
102.
As shown in the embodiment of FIG. 5A, the fluid paths 202 may be
exposed when the elongate members 402 are selectively moved
radially outwardly from the body 102. In this configuration, at
least portions of the elongate members 402 no longer cover the
inlets 204 of the fluid paths 202. In one embodiment, two or three
fluid paths 202 may be disposed within the channel 114 between each
pair of adjacent support regions 404. In one or more embodiments,
less than 3 or more than 4 fluid paths 202 may be disposed in the
channels 114 between adjacent support regions 404.
The elongate members 402 described herein may be made of flexible,
elastic, pseudoelastic or superelastic materials that enable
portions of the elongate members 402 to be repeatedly bent outward,
away from the body 102 of the sheath 600, and returned to a flat
configuration where the elongate members 402 are received back into
the channels 114. The material may also preferably be biocompatible
material. Examples of such materials may include, but are not
limited to, shape memory materials such as Nitinol, gold-cadmium,
copper-zinc or other materials, including ferro-magnetic shape
alloys.
FIG. 6B illustrates a close-up view of the sheath 600 of FIG. 6A to
clarify the interaction between the channel 114, elongate members
402, and support regions 404, when the elongate members 402 have
been selectively moved to extend radially outwardly from the body
102. As shown in the embodiment of FIG. 6B, the support region 404
extends across the channel 114 and over the elongate member 402 to
restrain the portion of the elongate member 404 disposed under the
support region 404 from being extended away from the body 102.
Portions of the elongate member that are not restrained by the
support region 404 may be extended outward as shown.
Accordingly, as discussed above, the one or more fluid paths 202
disposed within the channel 114 between the support regions 404 are
exposed to allow blood, or other fluid within the vasculature of
the patient, to flow into the device receiving lumen 208 of the
sheath 600. Also, in one embodiment, the support region 404 is
preferably not rigidly attached or secured to the elongate member
402 so that the elongate member 402 may slide longitudinally
relative to the support region 404.
FIG. 6C illustrates a transverse cross-sectional view of the sheath
600 of FIG. 6A. The cross-sectional plane of FIG. 6C is positioned
along the longitudinal length of the body 102 where the elongate
members 402 are extended outward between a pair of adjacent support
regions 404. As shown in the embodiment of FIG. 6C, the elongate
members 402 may extend radially outwardly from the body 102. In one
embodiment, the elongate members 402 may selectively extend
radially outwardly from the body 102 to distance D5 of between
about 0.5 mm and 1.5 mm. In one or more other embodiments, the
distance D5 may be between about 0.75 mm and 1.25 mm. In yet
another embodiment, the distance D5 may be less than 0.5 mm or
greater than 1.5 mm.
FIG. 7A, similar to FIG. 6C, illustrates a transverse
cross-sectional view of an embodiment of a sheath 700 similar to
the sheath 600 shown in FIG. 6A. The sheath 700 of FIG. 7A has been
inserted into a vascular conduit 10. The elongate members 402 have
been selectively moved radially outwardly from the body 102 to push
against the inside of the vascular wall 30. In one embodiment, the
force of the extended elongate members 402 against the vascular
wall 30 may expand the vascular wall 30 away from the body 102 to
create spaces 302 where blood or other fluid within the vascular
conduit 10 can enter the device receiving lumen 208 through the
various fluid paths 202.
In this way, when the elongate members 402 are selectively moved
radially outwardly from the body 102, fluid, such as blood within
the conduit 10 of a patient's vasculature 20 residing in the spaces
302, may enter into the device receiving lumen 208 through the
various fluid paths 202. Once the blood enters the device receiving
lumen 208, the blood may continue to be pumped through the vascular
conduit 10, carrying oxygen to the tissue of the patient as
needed.
FIG. 7B illustrates another cross-sectional view of the sheath 700
disposed within a vascular conduit 10. The elongate members 402
have been extended radially outwardly from the body 102 to push
against the vascular wall 300 and create space 302 between the
sheath 700 and vascular wall 30. As discussed above, the support
regions 404 restrain portions of the elongate member 402 from
extending radially from the body 102.
One will appreciate that a number of channel 114 configurations and
patterns may be implemented, which achieve the same function as the
channels 114 already herein described. For example, FIG. 8
illustrates a number of elongate members 402 received into channels
114 disposed along the working length of an embodiment of a sheath
800. In this embodiment, portions of the elongate members 402
disposed between support regions 404 are staggered relative to
parallel elongate member 402 portions. This is due to the staggered
pattern of support regions 404 around the circumference and along
the working length of the body 102.
Alternatively, FIG. 9 illustrates a helical pattern of channels
114, elongate members 402, and support regions 404, disposed around
the circumference and along the working length of the body 102 of a
sheath 900. In the illustrated embodiment, the channels 114 and
elongate members 402 wrap around the body 102 at an angle, forming
a helical pattern. Additionally, or alternatively, the support
regions 404 may be staggered so that they do not align with support
regions 404 that span parallel channels 114.
FIGS. 10 and 11 illustrate how the elongate members 402 may be
selectively moved to extend radially outwardly from the body 102 of
a sheath. As discussed above with reference to FIG. 1, a hub 110
may be disposed at the proximal end 104 of the sheath 100. A
cross-sectional view of an embodiment of a hub 110 is illustrated
in FIGS. 10 and 11 is similar to the hub 110 of FIG. 1. In the
illustrated embodiment, the hub 110 may include a first portion
1002 and a second portion 1004. The first portion 1002 may be
rigidly attached to the elongate members 402 and the second portion
1004 may be rigidly attached to the body 102. In FIG. 10, the hub
110 is configured so that the elongate members 402 do not extend
radially outwardly from the body 102.
In one embodiment, the first portion 1002 and the second portion
1004 of the hub 110 may be biased away from one another but held
together, as shown in FIG. 10, via a clip 1006 that prevents the
first portion 1002 from moving distally away from the second
portion 1004. The clip 1006 may be manipulated by a push tab 1008
that retains the clip 1006 around the first portion 1002 and locks
the first portion 1002 to the second portion 1004 of the hub. The
push tab 1008 may be biased to rest in the position illustrated in
FIG. 10 by a biasing member 1010 that maintains the locked
configuration shown.
FIG. 11 illustrates how a manipulation of the hub 110 may
selectively move the elongate members radially outwardly from the
body 102. For example, in the illustrated embodiment, the push tab
1008 may be pressed downward, as indicated by the arrows above the
push tab 1008. The clip 1006 is subsequently pushed down to release
the clip from the first portion 1002. As discussed above, the first
portion 1002 may be biased away from the second portion 1004 by one
or more biasing members 1012. Thus, in the illustrated embodiment,
when the push tab 1008 is moved down, the clip 1006 releases the
first portion 1002 and the one or more biasing members 1012 move
the first portion 1002 distally from the second portion 1004.
As noted above, the first portion 1002 may be secured to the
elongate members 402 and the second portion may be secured to the
second portion 1004. Thus, when the first portion 1002 of the hub
110 moves distally from the second portion 1004 of the hub 110, the
total longitudinal distance between the tip 116 of the sheath 100,
where the elongate members 402 may terminate distally, and the
first portion 1002 is reduced relative to the distance between the
tip 116 and the second portion 1004. In this configuration, the
elongate members 402 may tend to bend or extend radially outwardly
from the body 102. Specifically, the elongate members 402 may
extend radially outwardly from the body between the support regions
404 as illustrated in FIG. 11. In this way, the elongate members
114 may operatively cooperate with the channels 114 to fluidly
control fluid access into the device receiving lumen 208 of the
body 102 through the plurality of fluid paths 202 by selectively
closing the inlets 204.
In one embodiment of the present invention, the elongate members
402 may be heat set expanded at portions along the length of the
elongate members 402 that lie between adjacent support regions 404.
The heat set expansion may be done while the first and second
portions 1002, 1004 of the hub 110 are separated, so as to allow
the elongate members 402 to expand outwardly, as described above.
In this embodiment, the elongate members 402 would be expanded
outwardly in an initial state. In preparation for insertion of the
sheath into the vasculature of a patient, the elongate members 402
may be pulled inwardly towards the body 102 of the sheath 100.
Pulling the elongate members 402 inwardly toward the body 102 may
be done, for example, by manipulating the hub 110 so that the first
portion 1002 is connected to the second portion 1004, as described
above.
Along these lines, once the sheath 100 has been inserted into the
vasculature of a patient, the first portion 1002 of the hub 110 can
be gradually released to move distally from the second portion 1004
of the hub 110, resulting in the elongate members 402 returning to
the initial expanded state as shown in FIG. 11. Such an embodiment,
including the heat set elongate members 402 described above, may
ensure that each elongate member 402 expands consistently from one
portion between adjacent support regions 404 to another. That is,
each portion of elongate member 402, which are disposed between two
adjacent support regions 404, may expand the substantially same
distance away from the body 102 between each support region
202.
FIG. 12 illustrates a longitudinal cross-section view of yet
another embodiment of an elongate member 402 that may also ensure
equal expansion of the elongate members 402 between support regions
404 along the length of the body 102. In the illustrated
embodiment, each elongate member 402 comprises a thin ribbon 1202
and an inflation tube 1204 disposed between the ribbon 1202 and the
body 102.
In the illustrated embodiment, the inflation tube 1204 may include
one or more holes 1206 and a ballooning membrane 1208 disposed over
the holes 1206. The holes 1206 and ballooning membrane 1208 of the
inflation tube 1204 may be positioned between adjacent support
regions 404 along the length of the body 102. In this embodiment, a
fluid or gas may pass through the inflation tube 1204 and exit the
holes 1206 to inflate the ballooning membrane 1208, creating a
balloon 1210 between the ribbon 1202 and body 102. The balloons
1210 may inflate between adjacent support regions 404, thus pushing
portions of the ribbon 1202 outwardly from the body 102 between the
support regions 1202.
In such an embodiment, the first portion 1002 of the hub 110 may
first be moved distally from the second portion 1004 of the hub 110
before expansion of the balloons 12010. This would allow the ribbon
1202 of the elongate member 402 to freely move relative to the body
102. As such, the balloons 1210 may push portions of the ribbon
1202 outwardly from the body 102 between support regions 404, as
described above and shown in FIG. 12.
FIG. 13 also shows an embodiment of an elongate member 402 that may
ensure equal expansion between support regions 404 along the length
of the body 102. For example, FIG. 13 illustrates an elongate
member 402 that comprises a plurality of thin ribbon sections
1302a, 1302b and an elongate active member 1304. In one embodiment,
the active member 1304 may be secured to the first portion 1002 of
the hub 110 and be moveable relative to the body 102. Also, the
active member 1304 may be rigidly secured to a proximal end 1306 of
each of the ribbon sections 1302a, 1302b. In the illustrated
embodiment of FIG. 13, the active member 1304 is rigidly attached
to the ribbon sections 1302a, 1302b by extending up through the
ribbon sections 1302a, 1302b. In one or more other embodiments, the
active member 1304 may be rigidly secured to each ribbon section
1302a, 1302b in various other ways. For example, in one embodiment,
the active member 1304 may be adhered using an adhesive or welded
to the proximal end 1306 of each ribbon section 1302a, 1302b.
Furthermore, in one embodiment, the distal end 1308 of each ribbon
section 1302a, 1302b may be rigidly secured to a support region
404. In this way, as shown in the expanded configuration
illustrated in FIG. 13, a distal movement of the active member 1304
relative to the body 102 and support regions 404 may cause each
ribbon section 1302a, 1302b of the elongate member to expand
outwardly from the body 102 when the first portion 1002 of the hub
110 is moved distally from the second portion 1004 of the hub
110.
FIG. 13 also shows an embodiment of an active member 1304 that
includes one or more fluid paths 1310 that correspond in position
to the fluid paths 202 of the body 102 when the ribbon sections
1302a, 1302b have been extended outwardly from the body 102. In
such an embodiment, fluid, such blood flowing through the
vasculature of a patient, may pass through fluid paths 1310 and 202
from outside the body 102 of the sheath into the device receiving
lumen 208, as described with reference to other embodiments
described above.
Accordingly, when the first portion 1002 of the hub 110 is not
moved distally from the second portion 1004 of the hub 100, the
fluid paths 1310 of the active member 1304 may not align with the
fluid paths 202 of the body 202. Thus, if the first portion 1002 of
the hub 110 is still connected to, or has been returned to, the
second portion 1004 of the hub 110, the ribbon sections 1302a,
1302b will cover the fluid paths 1310 and the fluid paths 1310 of
the active member 1304 will not align with the fluid paths 202 of
the body 102, thus blocking fluid flow into the device receiving
lumen 208.
In any of the embodiments described above, the elongate members 402
may be selectively returned to the body 102 after being extended
outwardly by locking the first and second portions 1002, 1004 of
the hub 110 back together. This may be accomplished by pressing the
two portions 1002, 1004 together while simultaneously pressing the
push tab 1008 down. The push tab 1008 may then be released so that
the clip 1006 prevents the first portion 1002 from moving distally
away from the second portion 1004, as illustrated in FIG. 10. It
will be appreciated that the push tab 1008 may be manipulated in a
variety of other way, such as, for example, pneumatically,
hydraulically, magnetically, or the like. Also, the clip 1006 and
first and second portions 1002, 1004 may take various other forms
and configurations in other embodiments while still performing the
same functions as described herein.
In light of the foregoing description, a method 1400 of performing
an intravascular procedure, while maintaining a fluid path through
a vascular conduit of a patient may include a first step 1402 of
providing a procedural sheath as described herein. Next, the method
1400 may include the step 1404 of advancing the procedural sheath
into a vascular conduit of a patient. The method 1400 may also
include the step 1406 of selectively moving the elongate members of
the procedural sheath radially outwardly from the body of the
sheath. Furthermore, the method 1400 may include a step 1408
comprising advancing a procedural device into the device receiving
lumen of the body.
Additionally, the method may include further steps of withdrawing
the procedural device from the device receiving lumen and moving
the elongate member radially inwardly toward the body of the
sheath. The procedural sheath may then be withdrawn from the
vascular conduit of the patient.
In order to advance the procedural sheath into a vascular conduit
of a patient, a medical professional may first create an insertion
site for access into the vasculature of a patient as required by a
wide range of procedures. As discussed above, such procedures may
range from those that require extended periods time inside the
vasculature of a patient as well as insertion into small diameter
vasculature in the patient's extremities. For example, the
procedural sheath of the present disclosure may be inserted into
the femoral artery of a patient and advanced through the conduit of
the femoral artery to the heart. Also, for example, the procedural
sheath of the present disclosure may be inserted into the
vasculature anterior to the knee of a patient and advanced distally
through the vasculature towards the patient's ankle or foot.
In one implementation of the method described herein, the
procedural device may include a guidewire. In one embodiment, the
procedural device may include an embolic catheter used for the
delivery of embolic coils to occlude embolisms. In yet another
embodiment, the procedural device may include a balloon catheter
configured to deliver a stent or valve into the vasculature
surrounding the heart. One will appreciate that numerous procedural
devices may be advance through the procedural sheath of the present
disclosure according to various embodiments of the method described
herein.
The articles "a," "an," and "the" are intended to mean that there
are one or more of the elements in the preceding descriptions. The
terms "comprising," "including," and "having" are intended to be
inclusive and mean that there may be additional elements other than
the listed elements. Additionally, it should be understood that
references to "one embodiment" or "an embodiment" of the present
disclosure are not intended to be interpreted as excluding the
existence of additional embodiments that also incorporate the
recited features. Numbers, percentages, ratios, or other values
stated herein are intended to include that value, and also other
values that are "about" or "approximately" the stated value, as
would be appreciated by one of ordinary skill in the art
encompassed by embodiments of the present disclosure. A stated
value should therefore be interpreted broadly enough to encompass
values that are at least close enough to the stated value to
perform a desired function or achieve a desired result. The stated
values include at least the variation to be expected in a suitable
manufacturing or production process, and may include values that
are within 5%, within 1%, within 0.1%, or within 0.01% of a stated
value.
A person having ordinary skill in the art should realize in view of
the present disclosure that equivalent constructions do not depart
from the spirit and scope of the present disclosure, and that
various changes, substitutions, and alterations may be made to
embodiments disclosed herein without departing from the spirit and
scope of the present disclosure. Equivalent constructions,
including functional "means-plus-function" clauses are intended to
cover the structures described herein as performing the recited
function, including both structural equivalents that operate in the
same manner, and equivalent structures that provide the same
function. It is the express intention of the applicant not to
invoke means-plus-function or other functional claiming for any
claim except for those in which the words `means for` appear
together with an associated function. Each addition, deletion, and
modification to the embodiments that falls within the meaning and
scope of the claims is to be embraced by the claims.
The terms "approximately," "about," and "substantially" as used
herein represent an amount close to the stated amount that still
performs a desired function or achieves a desired result. For
example, the terms "approximately," "about," and "substantially"
may refer to an amount that is within less than 5% of, within less
than 1% of, within less than 0.1% of, and within less than 0.01% of
a stated amount. Further, it should be understood that any
directions or reference frames in the preceding description are
merely relative directions or movements. For example, any
references to "up" and "down" or "above" or "below" are merely
descriptive of the relative position or movement of the related
elements. The present invention may be embodied in other specific
forms without departing from its spirit or essential
characteristics. The described embodiments are to be considered in
all respects only as illustrative and not restrictive. The scope of
the invention is, therefore, indicated by the appended claims
rather than by the foregoing description. All changes which come
within the meaning and range of equivalency of the claims are to be
embraced within their scope
The present invention may be embodied in other specific forms
without departing from its spirit or essential characteristics. The
described embodiments are to be considered in all respects only as
illustrative and not restrictive. The scope of the invention is,
therefore, indicated by the appended claims rather than by the
foregoing description. All changes which come within the meaning
and range of equivalency of the claims are to be embraced within
their scope.
* * * * *